Drugs
A 7/24-7/28/18 FDA inspection at Hunan Norchem Pharmaceutical Co., Hunan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API) , according to a 1/9 Warning Letter. Specific deviations were: * · failing to prepare and use production and control records for each
Drugs
FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium). In a revised drug safety alert, the agency says most events are among people who are intentionally misusing or abusing
Drugs
FDA has revised its document entitled “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which contains core educational messages for those involved. It also includes more information on pain management, including principles of acute and chronic pain management; non-
Drugs
FDA has released the FDA-483 issued following a 1/16-1/19 inspection at Shilpa Medicare Limited, Raichur, Karnataka, India. Observations in the form were: * equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates
Drugs
The Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association), says a Pennsylvania federal court should not grant a motion by Johnson & Johnson and its Janssen Biotech subsidiary to dismiss a suit brought by Pfizer over its biosimilar Inflectra (infliximab), which is trying
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Daito Kasei Kogyo Co. Okayama, Japan (1/18): FDA inspected the firm 7/2017 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed
Drugs
FDA has approved a CutisPharma NDA for Firvanq (vancomycin hydrochloride) oral solution for treating Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The company says that Firvanq will replace its FIRST-Vancomycin Unit-of-Use Compounding Kit, which has been available to pharmacists that
Drugs
FDA has released a draft guidance on “Qualified Infectious Disease Product Designation Questions and Answers.” The document provides information on implementing the FDA Safety and Innovation Act’s section on “Generating Antibiotic Incentives Now (GAIN),” which creates incentives for developing antibacterial and antifungal drug products that treat serious or life-
Drugs
FDA and Duke University’s Center for Health Policy have announced a 4/16 public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will help the agency develop a guidance on the subject. It will include discussion about various ways in which participation in clinical trials
Drugs
FDA has accepted for review a Theravance Biopharma and Mylan NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist for treating chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action target date of 11/13, and it has told the companies that an
Drugs
FDA has updated a guidance for Institutional Review Boards and Clinical Investigators to revise its “Payment for Research Subjects: Information Sheet” to clarify that reimbursement for travel expenses to clinical trial sites and associated costs (airfare, parking, and lodging) are acceptable under current practices. The updates were made based on
Drugs
FDA has issued Aradigm a complete response letter (CRL) on its NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with chronic Pseudomonas aeruginosa (P. aeruginosa) lung infections. The letter says the NDA cannot be approved in its present form, and provides recommendations
Drugs
FDA has approved an Advanced Accelerator Applications NDA for Lutathera (lutetium Lu 177 dotatate) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency says this is the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which
Drugs
FDA has tentatively approved a Perrigo ANDA for a generic version of Valeant Pharmaceutical’s Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%), indicated for topical treatment of acne vulgaris in patients 12 years of age and older. Branded market sales for the last 12 months were
Drugs
The Washington DC District Court has remanded to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the company’s Sensipar (cinacalcet hydrochloride). In its complaint, Amgen argued that FDA’s decision to grant an earlier pediatric exclusivity award to Johnson & Johnson’s
Drugs
FDA has cleared a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems” for treating cancer patients. The device uses proprietary technology to track and irradiate tumors in motion. “This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor
Drugs
The Justice Department has issued a memorandum outlining factors that department attorneys should consider when determining whether to seek dismissal of a whistleblower (qui tam) suit under the False Claims Act. The document notes there have been record increases in the number of whistleblower suits over the last few years.
Drugs
FDA has issued Braeburn Pharmaceuticals a complete response letter on an NDA for CAM2038, an investigational buprenorphine weekly and monthly depot injection for treating adults with opioid use disorder (OUD). In the letter, the agency requested additional information before approval could be considered. The company says the agency did not
Drugs
FDA has published a draft guidance, Hypertension: Developing Fixed-Dose Combination Drugs for Treatment, to assist drug sponsors in clinical development of fixed-dose combination drugs for treating hypertension. The guidance focuses on development of two-drug combinations of previously approved drugs, although FDA says the general approach is readily
Drugs
FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The drug was previously approved for treating adults with chronic idiopathic constipation (CIC). Approval was based on data from the company’s
Drugs
Endo says it is agreeing to an FDA request that it seek a temporary stay of its 10/2017 suit against FDA seeking a declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the 2013 Drug Quality and Security Act (DQSA) is
Drugs
FDA has granted Synthon Biopharmaceuticals a fast track designation for its investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazine (SYD985). The designation is for treating patients diagnosed with HER2-positive metastatic breast cancer that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced